Comparison · NCT00098059-sae
Part A (Single-dose of Famciclovir) vs Part B (Multiple-dose of Famciclovir): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Part A (Single-dose of Famciclovir) vs Part B (Multiple-dose of Famciclovir): serious adverse events. Trial comparisons, record NCT00098059-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00098059-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0 | 0 | 0.125 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0756 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0756 | 0.125 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Part A (Single-dose of Famciclovir) | Includes 27 patients enrolled in Part A. Two adolescent patients (13 to 18 years) were enrolled in Part A of this study under an amendment to the protocol to include adolescent aged patients. The amendment was rescinded in compliance with an FDA Pediatric Written Request and no further adolescent aged patients were enrolled. | 0 | 27 | EG000 |
| Group 2 | Part B (Multiple-dose of Famciclovir) | Includes 47 patients enrolled in Part B. Part B started only after pharmacokinetic (PK) data from Part A had been analyzed. One patient that participated in Part A of the study also participated in Part B. | 0 | 47 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Patients in Parts A and B of the study who experienced adverse events. These AEs are presented by system organ class for each age group in the safety population.
Source ClinicalTrials.gov
Trial
- Title
- Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection
- NCT number
- NCT00098059
- Phases
- PHASE3
- Conditions
- Herpes Simplex
- Interventions
- Famciclovir
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2009-05-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00098059?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
For software
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GET https://conductscience.org/api/comparisons/v1/NCT00098059-sae